Allergic Conjunctivitis
Conditions
Keywords
Allergic conjunctivitis
Brief summary
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.
Detailed description
Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.
Interventions
DRUGOlopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
OTHERDextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of allergic conjunctivitis; * Active signs and symptoms of ocular allergies; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History of dry eye; * Presence of ocular infection; * Presence of severe or serious ocular conditions; * Symptoms of allergic conjunctivitis; * Use of topical or systemic ocular medications as specified in protocol; * Ocular surgery or laser surgery within 6 months of study start; * Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours | Baseline, 3 hours | As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub. |
| Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours | Baseline, 3 hours | As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one study center in Canada.
Participants by arm
| Arm | Count |
|---|---|
| Patanol One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. | 6 |
| Tears Naturale II One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. | 7 |
| Total | 13 |
Baseline characteristics
| Characteristic | Patanol | Tears Naturale II | Total |
|---|---|---|---|
| Age Continuous | 36.0 years STANDARD_DEVIATION 10.4 | 39.9 years STANDARD_DEVIATION 11.2 | 38.1 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Canada | 6 participants | 7 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 2 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Time frame: Baseline, 3 hours
Population: All enrolled participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patanol | Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours | -0.38 Units on a scale | Standard Error 0.6 |
| Tears Naturale II | Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours | -1.15 Units on a scale | Standard Error 0.5 |
Primary
Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Time frame: Baseline, 3 hours
Population: All enrolled participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patanol | Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours | -1.63 Units on a scale | Standard Error 0.6 |
| Tears Naturale II | Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours | -1.11 Units on a scale | Standard Error 0.2 |